Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Meningococcen B vaccin

Generic name
Meningococcen B vaccin
Brand name
ATC Code
J07AH09

Pharmacokinetics in children

Not applicable

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

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Dosages

Vaccination against invasive meningococcal diseases caused by Neisseria meningitidis groups B
  • Intramuscular
    • 2 months up to 18 years
      [1] [2]

      • BEXSERO

        • 2 months to 6 months: 0.5 ml/dose
          Vaccination schedule as follows:. 3 doses at least 1 month interval OR 2 doses with at least 2 month interval. Booster dose of at age 12-15 months, at least 6 months after primary series.
        • 6 months to 24 months: 0.5 ml/dose.
          2 doses with at least 2 month interval.
          Booster dose:
          > 6-11 months: Booster dose in second year of life, at least 2 mnd after primary series
          > 12-23 months: Booster dose 12-23 months after primary series.
        • ≥ 2 years: 0.5 ml/dose.
          Vaccination schedule as follows: 2 doses at least 1 mnd interval. 
          Boosterdose only recommended for children with a continued risk for exposure to meningococci disease

        TRUMENBA

        • ≥ 10 years: 0.5 ml/dose
          Vaccination as follows:
          - 2 doses: interval of 6 months between dose 1 and 2
          - 3 doses: interval of at least 1 month between doses 1 and 2 and interval of at least 4 months between doses 2 and 3

        A booster dose may be given in persons in whom the risk of invasive meningococcal disease is persistent

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Bexsero
Children ≥ 11 years of age:

Very common (> 10%): headache, nausea, myalgia, arthralgia, reactions at the injection site (such as pain, erythema, tenderness and hardening), malaise.

Also reported are allergic (anaphylactic) reactions, syncope, vasovagal reactions, meningeal excitation (such as neck stiffness or photophobia), rash, fever, injection site reactions (including extensive swelling of vaccinated limb, blisters, nodus that may persist > 1 month), lymphadenopathy.

Infants and children < 11 years of age:

Very common (> 10%): eating disorders, drowsiness, unusual crying, headache, diarrhea, vomiting, skin rash (in children 12 to 23 months of age), arthralgia, fever ≥ 38°C, injection site reactions (such as pain, erythema, swelling, tenderness and hardening), irritability.

Uncommon (0.1-1%): (febrile) seizures, pallor (rarely after booster), eczema, fever ≥ 40°C.

Rare (0.01-0.1%): Kawasaki disease, urticaria.

Also reported are: allergic (anaphylactic) reactions, hypotonic-hyporesponsive episode, meningeal excitation (such as neck stiffness or photophobia), syncope, vasovagal reactions, injection site reactions (including extensive swelling of vaccinated limb, blisters, nodus that may persist > 1 month), lymphadenopathy.

Trumenba
Children > 10 years of age:

Very common (> 10%): chills, fatigue, redness, swelling and pain at injection site. Headache. Diarrhea, nausea. Muscle and joint pain.

Common (1-10%): vomiting. Fever > 38°C.

In addition, allergic reactions have been reported.

Children 2-10 years of age:

Very common (> 10%): headache, diarrhea, vomiting, muscle pain, joint pain, fever, fatigue, and pain, swelling and redness at the injection site.

Children 1-2 years of age:

Very common (> 10%): feeling drowsy, irritability, decreased appetite, fever and pain, swelling and redness at the injection site.

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Cholera vaccines
J07AE01
Haemophilus influenzae B vaccines
J07AG01
Meningococcal vaccines
J07AH07
J07AH08
Pertussis vaccines
J07AJ52
Pneumococcal vaccines
J07AL02
Tuberculosis vaccines
J07AN01
Typhoid vaccines
J07AP03
J07AP01

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References

  1. Pfizer Europe MA EEIG, SmPC Trumenba (EU/1/17/1187) Rev 15, 29-11-23, www.ema.europa.eu
  2. GSK Vaccines S.r.l, SmPC Bexsero (EU/1/12/812) Rev 33, 19-07-2023, www.ema.europa.eu

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Changes

Changes